The present invention relates to an implantable support apparatus and to a method of using and to a method of making an implantable support apparatus.
An implantable support, such as a sheet or patch of flexible material, is used to provide additional support to weakened or destabilized tissue of a patient. Such implantable supports are used to treat a variety of conditions, including, for example, closing hernias and providing suburethral stabilization. The support may be formed of biological tissue or a synthetic material.
Some materials currently being used to manufacture such supports fail to attach adequately to surrounding tissue or experience undesirable deformation after implantation. Such conditions often require an additional surgical procedure and/or result in discomfort to the patient.
In one particular procedure, commonly known as a transvaginal or pubovaginal sling procedure, a patch or strip of biological tissue is used to provide suburethral stabilization for female patients experiencing bladder dysfunction, such as stress urinary incontinence. However, ends of the strip are friable and tend to weaken or rupture upon penetration by a relatively large needle. In addition, conventional biological strips are not easily integrated into the surrounding tissue due to their biocompatibility.
One aspect of the present invention provides an implantable support apparatus that includes a sheet of flexible material having first and second end portions that are spaced apart from each other by a length of the material. First apertures extend through the sheet of material near each of the end portions. A plurality of second apertures, which preferably are larger than the first apertures, extend through an intermediate portion of the sheet of material located between the first and second end portions.
Another aspect of the present invention provides an implantable tissue support that includes a sheet of flexible, biocompatible biological tissue material. The sheet of tissue material has first and second end portions. The end portions are spaced apart from each other and a plurality of apertures are formed through the sheet at locations spaced from and intermediate the end portions of said sheet of tissue material.
Yet another aspect of the present invention provides a method of using an implantable sheet of biocompatible material. The method includes providing a sheet of flexible biocompatible material. First apertures are formed through the sheet near each of first and second end portions and a plurality of second apertures are formed through a portion of the sheet located intermediate the first and second end portions. Sutures are inserted through selected ones of the first apertures at the end portions for connection to desired tissue of the patient. The sheet of material is connected to the desired tissue using the sutures, whereby the patient""s tissue engaging the intermediate portion of the sheet of material can embed itself into the second apertures to help hold the implanted sheet at a desired position.
Still another aspect of the present invention provides a method of making an implantable support apparatus. A sheet of flexible biocompatible material is provided. The sheet has first and second end portions that are spaced apart from each other by a length of the material. First apertures are formed through the sheet near each of the first and second end portions. A plurality of second apertures are formed through a portion of the sheet located intermediate the first and second end portions.